immunogenicity, safety & reactogenicity of gsk vaccine tritanrix™-hepb/hib2.5 compared to gsk vaccine tritanrix™-hepb/hiberix™

Conditions: Haemophilus Influenzae Type b

Summary: in order to reduce the amount of thiomersal in its vaccines, gsk biologicals has developed a dtpw-hbv vaccine with low thiomersal content (tritanrix™- hepb low thio). this vaccine is to be used in combination with a hib low dose vaccine containing 2.5µg of prp antigen (hib 2.5). the purpose of this study is to generate clinical data with tritanrix™-hepb low thio vaccine when extemporaneously mixed with hib 2.5 vaccine. the control group will receive tritanrix™-hepb/hiberix™. subjects received primary vaccination in study 208108/091 (double blind). of these subjects 50% were randomised to participate in the prp challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study dtpwhbv=hib2.5-093 (101477).


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * born after a gestation period of 36 to 42 weeks. * born to a mother proven seronegative for hbsag. exclusion criteria: * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine, with the exception of oral polio vaccine (opv). * bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life. * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b and/or hib. * history of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis b and/or hib disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or history. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.

Keywords: pertussis tetanus hiberix™ hepatitis b dtpw-hbv vaccine tritanrix™-hepb haemophilus influenzae type b diphtheria hib vaccine